País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
ALBUMIN (HUMAN)
EURO ASIA MEDICO PTE. LTD.
B05AA01
4.5% w/v
INJECTION
ALBUMIN (HUMAN) 4.5% w/v
INTRAVENOUS
Prescription Only
BIO PRODUCTS LABORATORY LIMITED
ACTIVE
1992-10-09
MyGPS Europe Limited Tel: 020 8863 9700 Job No: 1567 Project Name: Zenalb 4.5 Leaflet Dual Malaysia / Singapore Contact: Wioletta Nisiobedzka Client Order No. P5520 Date: 23/05/2014 Proof No. 5 Operator: Hema Joshi Doc. Size: 150 x 220mm PACKAGE LEAFLET: INFORMATION FOR THE USER ZENALB ® 4.5 HUMAN ALBUMIN 4.5% SOLUTION ADNMYSG1 1. NAME OF MEDICINAL PRODUCT ZENALB ® 4.5, Human Albumin 4.5% Solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE INGREDIENTS Human albumin. 2.2 QUANTITATIVE COMPOSITION ZENALB ® 4.5 is a clear, yellow to green, sterilised solution. It is a solution containing 40-50g/L of plasma protein of which not less than 95% is albumin. Zenalb ® 4.5 is free from plasma proteins associated with the blood clotting mechanism and blood group antibodies. 3. PHARMACEUTICAL FORM ZENALB ® 4.5 is an isotonic solution for intravenous use. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZENALB ® 4.5 is used for albumin replacement in patients with albumin and blood volume deficiency. ZENALB ® 4.5 is indicated in: i) the clinical management of hypovolaemic shock associated with blood loss, trauma and surgical procedures, ii) the clinical management of burn injuries. It should be used as part of a recognised method of resuscitation and, depending upon the particular regimen being followed, may be the principal component of the intravenous fluid therapy or given as an adjunct to crystalloid infusions, iii) fluid replacement regimens in therapeutic plasma exchange. In the plasma exchange the volume of plasma removed may be replaced in whole or part by an equivalent volume of ZENALB ® 4.5, but the volume of any anticoagulant given must be taken into account in calculating the albumin replacement volume, iv) the resuspension of recycled red blood cells during major surgical procedures, e.g. liver transplant. ZENALB ® 4.5 has an aluminum content of not more than 200ug/L Llegiu el document complet
Star Creative Tel: 07986 500108 Job No: 50144 Text Sizes: Main Body Text 7pt Line Spacing 8pt Fonts used: Helvetica Neue 55 Roman 75 Bold Project Name: Zenalb 4.5 PIL Singapore ADSG5 Contact: Laura Ambrose Client Order No. P75523 Date: 30/10/2023 Proof No. 1 Operator: Hema Joshi Doc. Size: 200 x 280mm PACKAGE LEAFLET: INFORMATION FOR THE USER ZENALB 4.5 HUMAN ALBUMIN 4.5% SOLUTION ADSG5 1. NAME OF THE MEDICINAL PRODUCT Zenalb 4.5 45 g/l solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zenalb 4.5 is a solution containing 45 g/l (4.5%) of total protein of which at least 95% is human albumin. A vial of 100 ml contains 4.5 g of human albumin. Zenalb 4.5 has a mildly hypooncotic effect. Excipient with known effect: Zenalb 4.5 contains approximately 100-160 mmol/l sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. A clear, slightly viscous liquid, it is almost colourless, yellow, amber or green. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zenalb 4.5 is indicated in all patients for the restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The concentration of the albumin preparation, dosage and the infusion- rate should be adjusted to the patient’s individual requirements. POSOLOGY The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume, and not plasma albumin levels, should be used to determine the dose required. If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include: - arterial blood pressure and pulse rate - central venous pressure - pulmonary artery wedge pressure - urine output - electrolyte - haematocrit/haemoglobin METHOD OF ADMINISTRATION Human albumin can be directly administered by the intravenous route. The infusion rate should be Llegiu el document complet